Tocilizumab Intravenous - Cigna
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Drug and Biologic Coverage Policy
Effective Date ............................................... 1/1/2021
Next Review Date......................................... 1/1/2022
Coverage Policy Number ............................... M0004
Tocilizumab Intravenous
Table of Contents Related Coverage Resources
Overview .............................................................. 1 COVID-19 Drug/Biologic Therapeutics
Coverage Policy...................................................1 Immunomodulators – Oral and Subcutaneous
FDA Approved Indications ...................................3 (Employer Group Benefit Plans)
Recommended Dosing ........................................3 Immunomodulators – Oral and Subcutaneous
General Background ............................................5 (Individual and Family Plans)
Coding/Billing Information ....................................7 Oncology Medications
References ..........................................................7
INSTRUCTIONS FOR USE
The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of
business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan
language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting
certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document
[Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may
differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan
document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit
plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage
mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific
instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable
laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular
situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for
treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support
medical necessity and other coverage determinations.
Overview
This coverage policy addresses the use of tocilizumab intravenous (Actemra®) for non-oncology indications. The
use of tocilizumab for oncology indications is addressed in a separate coverage policy (Oncology Medications).
Please refer to the related coverage policy links above.
Coverage Policy
Tocilizumab intravenous (Actemra®) is considered medically necessary when any of the following
criteria are met:
• Chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome
(CRS) OR cytokine release syndrome (CRS) associated with COVID-19
• Inflammatory Arthritis Associated with Checkpoint Inhibitor Therapy and ALL of the following:
o Documented failure or intolerance, contraindication per FDA label, intolerance, or not a
candidate for ONE steroid (for example, methylprednisolone, prednisone)
o Individual developed inflammatory arthritis while receiving a checkpoint inhibitor (for example,
Keytruda (pembrolizumab IV infusion), Opdivo (nivolumab IV infusion), Yervoy (ipilimumab IV
infusion), Tecentriq (atezolizumab IV infusion), Bavencio (avelumab IV infusion), Imfinzi
(durvalumab IV infusion))
Page 1 of 8
Drug and Biologic Coverage Policy: M0004o Prescribed by, or in consultation with a rheumatologist or an oncologist
• Polyarticular Juvenile Idiopathic Arthritis (PJIA) and BOTH of the following:
o Individual is 2 years of age or older
o Prescribed by, or in consultation with a rheumatologist or a prescriber who specializes in PJIA
• Rheumatoid arthritis and BOTH of the following:
o Documented failure or inadequate response, contraindication per FDA label, intolerance, or not a
candidate for ONE disease-modifying anti-rheumatic drug (DMARD) (for example, methotrexate,
leflunomide, sulfasalazine)†
† NOTE: An exception to this requirement can be made if the individual has already tried a biologic.
These individuals are not required to “step back” and try a DMARD.
o Prescribed by, or in consultation with a rheumatologist or a prescriber who specializes in rheumatoid
arthritis
• Still’s Disease and ALL of the following
o Documented failure or intolerance, contraindication per FDA label, intolerance, or not a candidate to
ONE corticosteroid (for example, prednisone)†
o Documented failure or intolerance, contraindication per FDA label, intolerance, or not a candidate to
ONE conventional synthetic disease-modifying antirheumatic drug (DMARD) (for example,
methotrexate) given for at least 2 months†
† NOTE: An exception to this requirement can be made if the individual has already tried a biologic.
These individuals are not required to “step back” and try a steroid or a conventional synthetic
DMARD.
o Prescribed by, or in consultation with a rheumatologist or a prescriber who specializes in Still’s
Disease
• Systemic Juvenile Idiopathic Arthritis (SJIA) and the following:
o Prescribed by, or in consultation with a rheumatologist or a prescriber who specializes in Systemic
Juvenile Idiopathic Arthritis (SJIA)
For Chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome
(CRS) OR cytokine release syndrome (CRS) associated with COVID-19, authorization is for 1 week (4
doses only)
For all other covered uses, initial authorization is up to 12 months.
Tocilizumab intravenous (Actemra) is considered medically necessary for continued use when the
individual has had a positive response to tocilizumab intravenous.
Reauthorization for up to 12 months.
When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and
site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and
adjusted based upon severity, alternative available treatments, and previous response to therapy.
Tocilizumab intravenous (Actemra) is considered experimental, investigational or unproven for ANY
other use including the following:
• Concomitant use with any other biologic including all non-tumor necrosis factor (non-TNF) biologics,
anti-TNF biologics, or oral immunomodulatory agents (for example, Otezla or Xeljanz/ Xeljanz XR)
• Crohn’s Disease
Note: Receipt of sample product does not satisfy any criteria requirements for coverage.
Page 2 of 8
Drug and Biologic Coverage Policy: M0004FDA Approved Indications
Rheumatoid Arthritis (RA)
Actemra (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active
rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic
Drugs (DMARDs).
Giant Cell Arteritis (GCA) – subcutaneous only
Actemra (tocilizumab) is indicated for the treatment of giant cell arteritis (GCA) in adult patients.
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Actemra (tocilizumab) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in
patients 2 years of age and older.
Systemic Juvenile Idiopathic Arthritis (SJIA)
Actemra (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in
patients 2 years of age and older.
Cytokine Release Syndrome (CRS)
Actemra (tocilizumab) is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced
severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older.
Recommended Dosing
FDA Recommended Dosing
Rheumatoid Arthritis
Actemra may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs as an
intravenous infusion or as a subcutaneous injection.
Recommended Intravenous Dosage Regimen:
The recommended dosage of Actemra for adult patients given as a 60-minute single intravenous drip infusion is
4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.
• Reduction of dose from 8 mg per kg to 4 mg per kg is recommended for management of certain dose-
related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia [see
Dosage and Administration (2.9), Warnings and Precautions (5.3), and Adverse Reactions (6.1)].
• Doses exceeding 800 mg per infusion are not recommended in RA patients [see Clinical Pharmacology
(12.3)].
Recommended Subcutaneous Dosage Regimen:
Patients less than 100 kg weight 162 mg administered subcutaneously every
other week, followed by an increase to every
week based on clinical response
Patients at or above 100 kg weight 162 mg administered subcutaneously every
week
When transitioning from Actemra intravenous therapy to subcutaneous administration administer the first
subcutaneous dose instead of the next scheduled intravenous dose.
Interruption of dose or reduction in frequency of administration of subcutaneous dose from every week to every
other week dosing is recommended for management of certain dose-related laboratory changes including
elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.9), Warnings
and Precautions (5.3), and Adverse Reactions (6.2)].
Giant Cell Arteritis
Page 3 of 8
Drug and Biologic Coverage Policy: M0004The recommended dose of Actemra for adult patients with GCA is 162 mg given once every week as a
subcutaneous injection in combination with a tapering course of glucocorticoids.
A dose of 162 mg given once every other week as a subcutaneous injection in combination with a tapering
course of glucocorticoids may be prescribed based on clinical considerations.
Actemra can be used alone following discontinuation of glucocorticoids.
• Interruption of dosing may be needed for management of dose-related laboratory abnormalities including
elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.9)].
• Intravenous administration is not approved for GCA.
Polyarticular Juvenile Idiopathic Arthritis
Actemra may be used alone or in combination with methotrexate. Do not change dose based solely on a single
visit body weight measurement, as weight may fluctuate.
Recommended Intravenous Dosage Regimen:
The recommended dosage of Actemra for PJIA patients given once every 4 weeks as a 60-minute single
intravenous drip infusion is:
Recommended Intravenous PJIA Dosage Every 4 Weeks
Patients less than 30 kg weight 10 mg per kg
Patients at or above 30 kg weight 8 mg per kg
Recommended Subcutaneous Dosage Regimen:
Recommended Subcutaneous PJIA Dosage
Patients less than 30 kg weight 162 mg once every 3 weeks
Patients at or above 30 kg weight 162 mg once every 2 weeks
When transitioning from Actemra intravenous therapy to subcutaneous administration, administer the first
subcutaneous dose instead of the next scheduled intravenous dose.
Interruption of dosing may be needed for management of dose-related laboratory abnormalities including
elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.9)].
Systemic Juvenile Idiopathic Arthritis
Actemra may be used as an intravenous infusion or as a subcutaneous injection alone or in combination with
methotrexate. Do not change a dose based solely on a single visit body weight measurement, as weight may
fluctuate.
Recommended Intravenous Dosage Regimen:
The recommended dose of Actemra for SJIA patients given once every 2 weeks as a 60-minute single
intravenous drip infusion is:
Recommended Intravenous SJIA Dosage Every 2 Weeks
Patients less than 30 kg weight 12 mg per kg
Patients at or above 30 kg weight 8 mg per kg
Recommended Subcutaneous Dosage Regimen:
Recommended Subcutaneous SJIA Dosage
Patients less than 30 kg weight 162 mg once every two weeks
Patients at or above 30 kg weight 162 mg once every week
When transitioning from Actemra intravenous therapy to subcutaneous administration, administer the first
subcutaneous dose when the next scheduled intravenous dose is due.
Page 4 of 8
Drug and Biologic Coverage Policy: M0004Interruption of dosing may be needed for management of dose-related laboratory abnormalities including
elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.9)].
Cytokine Release Syndrome (CRS)
Use only the intravenous route for treatment of CRS. The recommended dose of Actemra for treatment of CRS
given as a 60-minute intravenous infusion is:
Recommended Intravenous CRS Dosage
Patients less than 30 kg weight 12 mg per kg
Patients at or above 30 kg weight 8 mg per kg
Alone or in combination with corticosteroids
• If no clinical improvement in the signs and symptoms of CRS occurs after the first dose, up to 3
additional doses of Actemra may be administered. The interval between consecutive doses should be at
least 8 hours.
• Doses exceeding 800 mg per infusion are not recommended in CRS patients.
• Subcutaneous administration is not approved for CRS
General Considerations for Administration
• Actemra has not been studied in combination with biological DMARDs such as TNF antagonists, IL-1R
antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators because of the
possibility of increased immunosuppression and increased risk of infection. Avoid using Actemra with
biological DMARDs.
• It is recommended that Actemra not be initiated in patients with an absolute neutrophil count (ANC)
below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times
the upper limit of normal (ULN).
o Patients with severe or life-threatening CRS frequently have cytopenias or elevated ALT or AST
due to the lymphodepleting chemotherapy or the CRS. The decision to administer Actemra
should take into account the potential benefit of treating the CRS versus the risks of short-term
treatment with Actemra.
General Background
Pharmacology
Targeting IL-6 is a therapeutic option for treatment of chronic inflammatory diseases such as RA. (Schoels, 2013)
IL-6 has been shown to be involved in diverse physiological processes and is also produced by synovial and
endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as RA.
Actemra is an IL-6 receptor monoclonal antibody that binds to soluble and membrane-bound IL-6 receptors and
has been shown to inhibit IL-6-mediated signaling through these receptors.1 In CRS (reported in 79% to 94% of
patients receiving CAR T therapy), there are high levels of IL-6; therefore, IL-6 signaling is inhibited with Actemra
IV. (Actemra Prescribing Information, 2018, Yescarta Prescribing Information, 2017, Kymriah Prescribing
Information, 2017, Lee, 2014, NCCN/ASCO, 2019)
Professional Societies/Organizations
NCCN and American Society of Clinical Oncology (ASCO)
NCCN has guidelines in partnership with the American Society of Clinical Oncology (ASCO) [version 1.2019 –
November 14, 2018] for Management of Immunotherapy-Related Toxicities. (NCCN/ASCO, 2019)
In regard to CAR-T-cell-related toxicities, prompt and urgent attention is required to prevent progression. All
patients with Grade 2, 3, and 4 are recommended for treatment with Actemra. In patients with Grade 1 CRS,
Actemra is also listed as a therapeutic option for prolonged CRS in patients with significant symptoms and/or
comorbidities. For immune checkpoint inhibitor-related toxicities, infliximab or Actemra may be considered for
refractory or severe arthritis not responding to steroids and anti-inflammatory agents.
American College of Rheumatology
Page 5 of 8
Drug and Biologic Coverage Policy: M0004The 2011 ACR recommendations for the treatment of JIA (published prior to the approval of Actemra IV for PJIA)
propose initial DMARD treatment with MTX in most patients; however, sulfasalazine is recommended for patients
with enthesitis-related arthritis and may also be used in certain patients with sacroiliac arthritis. (Beukelman, 2011)
Updated guidelines from the American College of Rheumatology (ACR) for treatment of SJIA (2013) mention
Actemra as a second- or third-line agent in patients with active systemic features and varying degrees of synovitis
and in patients without active systemic features and varying degrees of synovitis; NSAIDs, systemic
glucocorticoids, Kineret, TNFis, and MTX are among other treatment options. (Ringold, 2013)
Guidelines from the American College of Rheumatology (ACR) [2015] have TNF inhibitors and non-TNF biologics
(such as Actemra) equally positioned as a recommended therapy following a trial of a conventional synthetic
DMARD (e.g., MTX, leflunomide, hydroxychloroquine, sulfasalazine). (Ito, 2004)
The American Board of Internal Medicine’s (ABIM) Foundation Choosing Wisely® Initiative:
The American College of Rheumatology Choosing Wisely® (2013) recommends a 3 month trial of methotrexate
(or another conventional non-biologic DMARD) unless contraindicated or other exceptions (e.g., high disease
activity and poor prognostic features) before initiating biologic therapy for rheumatoid arthritis.
Centers for Medicare & Medicaid Services - National Coverage Determinations (NCDs)
There are no CMS National Coverage Determinations for tocilizumab intravenous.
Other Uses with Supportive Evidence
Still’s disease presents in adults with features similar to those of SJIA.11 Actemra IV has been effective in reducing
fever, symptoms, and markers of inflammation in patients who were refractory to treatment with prednisone, MTX,
Kineret, and/or a TNF antagonist.11-20 Prospective, randomized, controlled trials are needed.
Other Uses without Supportive Evidence
There is insufficient evidence in the peer-reviewed published scientific literature to support safety and efficacy of
tocilizumab in uveitis.
Concurrent Use with a Biologic or with a Targeted Synthetic DMARD. Data are lacking evaluating
concomitant use of Actemra IV another biologic or with a targeted synthetic DMARD used for an inflammatory
condition. Combination therapy is generally not recommended due to a higher rate of AEs with combinations
and lack of data supportive of additional efficacy. (Furst, 2012, Xeljanz Prescribing Information, 2017) Note:
This does NOT exclude the use of conventional synthetic DMARDs (e.g., MTX, leflunomide,
hydroxychloroquine, and sulfasalazine) in combination with Actemra IV. Please note that this table is not all
inclusive.
Brand (generic name) Mechanism of Action
Cimzia (certolizumab pegol for SC injection) Inhibition of TNF
Enbrel (etanercept for SC injection) Inhibition of TNF
Erelzi™ (etanercept-szzs for SC injection) Inhibition of TNF
Humira® (adalimumab for SC injection) Inhibition of TNF
Amjevita™ (adalimumab-atto for SC injection) Inhibition of TNF
Cyltezo® (adalimumab-adbm for SC injection) Inhibition of TNF
Simponi® (golimumab for SC injection) Inhibition of TNF
Simponi® Aria™ (golimumab for IV infusion) Inhibition of TNF
Remicade® (infliximab for IV infusion) Inhibition of TNF
Inflectra™ (infliximab-dyyb for IV infusion) Inhibition of TNF
Renflexis® (infliximab-abda for IV infusion) Inhibition of TNF
Actemra® (tocilizumab for IV infusion) Inhibition of IL-6
Actemra® (tocilizumab for SC injection) Inhibition of IL-6
Kevzara™ (sarilumab for SC injection) Inhibition of IL-6
Orencia® (abatacept for IV infusion) T-cell costimulation modulator
Orencia® (abatacept for SC injection) T-cell costimulation modulator
Rituxan® (rituximab for IV infusion) CD20-directed cytolytic antibody
Page 6 of 8
Drug and Biologic Coverage Policy: M0004Truxima® (rituximab-abbs IV injection) CD20-directed cytolytic antibody
Kineret® (anakinra for subcutaneous SC injection) Inhibition of IL-1
Stelara® (ustekinumab for SC injection) Inhibition of IL-12/23
Stelara® (ustekinumab for IV infusion) Inhibition of IL-12/23
Siliq™ (brodalumab SC injection) Inhibition of IL-17
Cosentyx™ (secukinumab for SC injection) Inhibition of IL-17A
Taltz® (ixekizumab for SC injection) Inhibition of IL-17A
Ilumya™ (tildrakizumab-asmn for SC injection) Inhibition of IL-23
Skyrizi™ (risankizumab SC injection) Inhibition of IL-23
Tremfya® (guselkumab for SC injection) Inhibition of IL-23
Entyvio™ (vedolizumab IV infusion) Integrin receptor antagonist
Otezla® (apremilast tablets) Inhibition of PDE4
Xeljanz®, Xeljanz XR (tofacitinib tablets, tofacitinib extended-release Inhibition of the JAK pathways
tablets)
SC – Subcutaneous; TNF – Tumor necrosis factor; IL – Interleukin; IV – Intravenous; PDE4 – Phosphodiesterase 4; JAK –
Janus kinase.
Crohn’s Disease
In a 12-week pilot study conducted in Japan, 36 adults with active Crohn’s disease (Crohn’s Disease Activity
Index [CDAI] ≥ 150 and increased CRP) were randomized, in a double-blind fashion to Actemra 8 mg/kg IV
every 2 weeks; or alternating infusions of Actemra 8 mg/kg IV every 4 weeks and placebo (i.e., alternating with
placebo every 2 weeks), or to placebo every 2 weeks. (Ito, 2004) At baseline the CDAI means ranged from 287
to 306. Patients had been treated with corticosteroids, mesalamine-type drugs, metronidazole, or elemental diet.
Six patients in the placebo group, four patients on Actemra IV every 4 weeks and one patient on Actemra IV
every 2 weeks dropped out. The mean reduction in the CDAI score in the Actemra 8 mg/kg IV every 2 week
group was 88 points (from mean 306 to 218). Further studies are needed.
Coding/Billing Information
Note: 1) This list of codes may not be all-inclusive.
2) Deleted codes and codes which are not effective at the time the service is rendered may not be
eligible for reimbursement.
Considered Medically Necessary when criteria in the applicable policy statements listed
above are met:
HCPCS Description
Codes
J3262 Injection, tocilizumab, 1 mg
References
1. American College of Rheumatology: Don’t prescribe biologics for rheumatoid arthritis before a trial of
methotrexate (or other conventional non-biologic DMARDs). Choosing Wisely. Accessed March 8, 2019.
Available at URL address: http://www.choosingwisely.org/clinician-lists/american-college-rheumatology-
biologics-for-rheumatoid-arthritis/
2. Actemra® injection for intravenous infusion [prescribing information]. South San Francisco, CA: Genentech;
December 2018.
3. Beukelman T, Patkar NM, Saag KG, et al. 2011 American College of Rheumatology recommendations for the
treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment
of arthritis and systemic features. Arthritis Care Res (Hoboken). 2011;63(4):465-482.
4. De Bandt M, Saint-Marcoux B. Tocilizumab for multirefractory adult-onset Still's disease. Ann Rheum Dis.
2009;68(1):153-154.
5. Furst DE, Keystone EC, So AK, et al. Updated consensus statement on biological agents for the treatment of
rheumatic diseases, 2012. Ann Rheum Dis. 2013;72 Suppl 2:ii2-34.
Page 7 of 8
Drug and Biologic Coverage Policy: M00046. Genentech, Inc.. Actemra (tocilizumab) [product information]. South San Francisco, CA: Genentech, Inc.;
December 2018.
7. Ito H, Takazoe M, Fukuda Y, et al. A pilot randomized trial of a human anti-interleukin-6 receptor monoclonal
antibody in active Crohn’s disease. Gastroenterology. 2004;126:989-996.
8. Iwamoto M, Nara H, Hirata D, et al. Humanized monoclonal anti-interleukin-6 receptor antibody for treatment
of intractable adult-onset Still's disease. Arthritis Rheum. 2002;46(12):3388-3389.
9. Kymriah™ suspension for intravenous infusion [prescribing information]. East Hanover, NJ: Novartis
Oncology; August 2017.
10. Matsumoto K, Nagashima T, Takatori S, et al. Glucocorticoid and cyclosporine refractory adult onset Still's
disease successfully treated with tocilizumab. Clin Rheumatol. 2009;28(4):485-487.
11. McEvoy GK, ed. AHFS 2019 Drug Information. Bethesda, MD: American Society of Health-Systems
Pharmacists, Inc. 2019.
12. Nakahara H, Mima T, Yoshio-Hoshino N, et al. A case report of a patient with refractory adult-onset Still's
disease who was successfully treated with tocilizumab over 6 years. Mod Rheumatol. 2009;19(1):69-72.
13. NCCN/ASCO Management of Immunotherapy-Related Toxicities (Immune Checkpoint Inhibitor-Related
Toxicities) Clinical Practice Guidelines in Oncology (Version 1.2019 – November 14, 2018). © 2018 National
Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed March 4, 2019.
14. Perdan-Pirkmajer K, Praprotnik S, Tomšič M. A case of refractory adult-onset Still's disease successfully
controlled with tocilizumab and a review of the literature. Clin Rheumatol. 2010;29(12):1465-1467.
15. Puéchal X, de Bandt M, Berthelot JM, et al. Tocilizumab in refractory adult Still's disease. Arthritis Care Res
(Hoboken). 2011;63(1):155-159.
16. Rech J, Ronneberger M, Englbrecht M, et al. Successful treatment of adult-onset Still's disease refractory to
TNF and IL-1 blockade by IL-6 receptor blockade. Ann Rheum Dis. 2011;70(2):390-392.
17. Ringold S, Weiss PF, Beukelman T, et al. 2013 Update of the 2011 American College of Rheumatology
Recommendations for the treatment of juvenile idiopathic arthritis. Arthritis & Rheumatism.
2013;65(10):2499-2512.
18. Riera E, Olivé A, Narváez J, et al. Adult onset Still's disease: review of 41 cases. Clin Exp Rheumatol.
2011;29(2):331-336.
19. Sabnis GR, Gokhale YA, Kulkarni UP. Tocilizumab in Refractory Adult-Onset Still's Disease with Aseptic
Meningitis-Efficacy of Interleukin-6 Blockade and Review of the Literature. Semin Arthritis Rheum.
2011;40(4):365-368.
20. Schoels MM, van der Heijde D, Breedveld FC, et al. Blocking the effects of interleukin-6 in rheumatoid arthritis
and other inflammatory rheumatic diseases: systematic literature review and meta-analysis informing a
consensus statement. Ann Rheum Dis. 2013;72(4):583-589.
21. Singh JA, Saag KG, Bridges L Jr, et al. 2015 American College of Rheumatology guideline for the treatment
of rheumatoid arthritis. Arthritis Care Res. 2016;68(1):1-26.
22. Smolen JS, Landewe R, Breedvel FC, et al. EULAR recommendations for the management of rheumatoid
arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis.
2014;73(3):492-509. doi:10.1136.
23. Xeljanz® tablets [prescribing information]. New York, NY: Pfizer Inc; February 2016.
24. Yescarta™ suspension for intravenous infusion [prescribing information]. Santa Monica, CA: Kite Pharma;
October 2017.
25. Yoshimura M, Makiyama J, Koga T, et al. Successful treatment with tocilizumab in a patient with refractory
adult-onset Still's disease (AOSD). Clin Exp Rheumatol. 2010;28(1):141-142.
“Cigna Companies” refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through
such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna
Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health
Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc. © 2021 Cigna.
by Cigna Intellectual Property, Inc. © 2021 Cigna.
Page 8 of 8
Drug and Biologic Coverage Policy: M0004You can also read
